510(k) K161547

Transem and EchoGen Embryo Transfer Catheters by Origio A/S — Product Code MQF

K161547 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "Transem and EchoGen Embryo Transfer Catheters". The FDA issued a decision of Substantially Equivalent on March 9, 2017. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Origio A/S has at least 10 other 510(k) clearances on record.